We’ve been here before – a woman in come hither mode or able to plunge into come hither mode at a moment’s notice without the worry of being compromised by a minor skin blemish just below her hairline. See Stacy London and Welcome to Troy.
AbbVie pioneered advertising like this for Humira, a hugely costly and highly dangerous drug. Humira can be very useful for some severe arthritic and inflammatory bowel conditions, but the money lay in expanding its sales out into as wide a range of lifestyle conditions as possible. Psoriasis was one of those conditions. AbbVie produced an almost grotesque set of advertisements that felt a bit like “Come surf here in this Great White playground”.
Pharmaceutical advertising is nothing if not romantic. It wants you to think you can be restored to an Eden, where there are no difficult decisions to make. Where your life is not compromised by a condition that might require balancing the problems caused by the condition against the risks of a poison. Where there are no snakes in the grass or Great Whites in the water.
What does Otezla Do?
Having a Mab attached to your name adalimumab (Humira) or brodalumab (Siliq) is a license to print money at the moment even if your drug is an injectable and you’re hoping to persuade people with very little wrong with them to take it.
But Mab is not an action. It means monoclonal antibody – its a delivery system. Siliq acts on Interleukin – 17 (IL 17), Humira doesn’t. At least, Siliq is pitched as acting on IL 17, and other drugs in the pipeline are pitched as acting on IL 23. This all sounds new but its probably not. Lots of drugs have acted on IL 17 and 23 before this but you’d never know this.
Otezla? Otezla is not a Mab. It, apremilast, is pitched as a PDE 4 inhibitor – phosphodiesterase 4. This supposedly underpins an anti-inflammatory effect, and offers hope for people with severe psoriatic arthritis – it will reduce the swelling in their joints.
PDE 4 inhibitors have been around a long time. In the 1990s there were hopes that Rolipram would be a blockbuster – as an antidepressant. But it disappeared from the radar. Nothing ever vanishes though no matter how “demonic”.
Otezla does inhibit PDE 4 enzymes. And this may make it somewhat anti-inflammatory – but not particularly so. It apparently does not deliver the kinds of clinical benefits that would warrant the price being charged.
Another PDE4 inhibitor, Daliresp aka roflumilast, is being pitched for Chronic Obstructive Pulmonary Disease (COPD).
But no drug just does one thing either biochemically or clinically. Otezla can cause you to become suicidal and can cause birth defects.
Inhibiting PDE 4 may be what causes some people to become suicidal when they take it or to be at risk of giving birth to a child with birth defects if they take it after a successful come hither moment.
But then again it may be the fact that it is something else about it being an analogue of thalidomide that leads to these problems. Thalidomide may also have PDE 4 inhibitory properties – I don’t know. What we do know is that we still don’t know why it causes birth defects. It causes peripheral neuropathy, sexual dysfunction and birth defects – just like the SSRIs for instance do.
Thalidomide never went away. It ended up with a newly formed company called Celgene in the 1980s. In 1987, FDA gave Celgene a license for thalidomide for leprosy despite there being almost no cases of leprosy in the USA. The company put it into trials for multiple myeloma where it can produce marginal benefits and they could charge a high price.
They later marketed thalidomide’s left handed isomer – Revlimid aka lenalidomide – for multiple myeloma, again very profitably.
And now we have Otezla, basically the same molecule with some side chain tweaking.
It was a Celgene Dear Doctor letter warning about the risks of suicide and birth defects – see Here – which got some of us looking more closely. This led to Siliq and its risks of suicide – even though its supposedly working on something quite different.
Part of the reason to explore all this further was a letter from someone called Kim Papp to the BMJ in response to our Study 329 – which was all about ghostwriting and the hiding of data on suicidality. Papp thought our work smeared good companies and good researchers.
This letter, coming out of nowhere (rural Ontario) was so strange it deserved to be followed up. When you follow it up it seems Dr Papp runs a clinical trial mill through which many of these new drugs have gone resulting in publications that have all the signs of being ghostwritten.
Dr Papp also appears to think that psoriasis, and almost anything else you care to think of, is more likely to cause people to be suicidal than a fine pill like Otezla or Siliq or paroxetine.
Taking the Plunge
AbbVie pioneered adverts like the one above and the one below. But over the top efforts to get a drug in the drinking water by so called ethical companies go back a much longer way . Grunenthal, the original makers of thalidomide, pushed the promotional envelope to a grotesque extent. Thalidomide was a sleeping pill that among other things was promoted as Kinesaft – the kind of juice kids could be given when their parents were going out to the cinema (Kine).
Just when you thought it was safe to go back in the water.
Otezla and Siliq Takers Unite.
We would be interested to hear from anyone taking either of these two drugs about any side effects you may be having. Any evidence for peripheral neuropathy – any alteration in sensations from skin or nerves or bowel or anywhere in the body – would be particularly interesting. Or evidence of agitation, in particular agitation linked to being suicidal or homicidal. Or any evidence of effects on sexual functioning.